Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome

Peking University People's Hospital30 enrolled

Overview

The purpose of this paper is to analysis of therapeutic effect and immunological mechanism of low-dose IL-2 combined with rapamycin in the treatment of Sjogren's syndrome

A randomized, open clinical trial was designed. Patients will be randomly divided into three groups，including Ld-IL2 group, rapamycin group, Ld-IL2+rapamycin group. The improvement of clinical and laboratory indexes will be evaluated. Changes of immune cell subsets and cytokines will be monitored.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sjögren's Syndrome

Interventions

low-dose interleukin-2DRUG

low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10\~6 IU once twice a week, for 12 weeks.

rapamycinDRUG

Rapamycin 0.5ml was taken orally once per day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female, and aged 18-70 at the time of screening visit. 2. Patients with Sjogren's syndrome who meet the 2002 EULAR classification criteria. 3. If the standardized treatment is not effective or relapses, it is clinically necessary to give additional immunomodulatory treatment. 4. Disease activity: ESSDAI≥4 points. 5. The pregnancy test results of female subjects of childbearing age should be negative at screening and baseline. 6. The written informed consent form approved by the Ethics Committee of Peking University People's Hospital was signed and dated by the subject or legal representative. Exclusion Criteria: 1. Severe chronic liver, kidney and heart dysfunction. 2. Severe drug-resistant bacterial infections, such as bacteremia and septicemia. 3. Patients with tumor and tumor history. 4. Chronic respiratory failure. 5. Patients who are ineffective in high-dose hormone pulse therapy. 6. Those who use rituximab or other biological agents within 3 months. 7. Patients with active tuberculosis infection or potential tuberculosis infection. 8. There are obstacles that can't cooperate or cause interference in completing this research: such as mental patients.

Locations (1)

Peking university people's hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Proportion of Treg cells in peripheral blood

Proportion of Treg cells in peripheral blood will be detected by flowcytometry

Time frame: week 12

Secondary Outcomes

ESSDAI [potential score 0 - 123]

ESSDAI is \[European League Against Rheumatism (EULAR) Sjögrens Syndrome Disease Activity Index\]. Higher scores mean a worse outcome.

Time frame: week 12

Physician's Global Disease Activity VAS, (potential score 0 - 10)

Physician's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis). Higher scores mean a worse outcome.

Time frame: week 12

Patient's Global Disease Activity VAS, (potential score 0 - 80)

Patient's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis). Higher scores mean a worse outcome.

Time frame: week 12

Rate of Participants with adverse effects associated with experimental drugs

Adverse effects include fever, rash, abnormal liver function, rate of new-onset infection and any abnormal measures associated with low-dose IL-2 therapy, and oral ulcer, rash, hypertension, anemia, arthralgia, diarrhea and any abnormal measures associated with rapamycin therapy.

Time frame: week 12

Data from ClinicalTrials.gov

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